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Deceased.
From the Mellen Center for Multiple Sclerosis Treatment and Research, Department of Neurology (Drs. Cohen, Fischer, and Rudick), Cleveland Clinic Foundation, OH; Center for Research Methodology and Biometrics (Dr. Cutter), AMC Cancer Center, Lakewood, CO; Department of Neurology (Dr. Goodman), University of Rochester, NY; Department of Neurology (Dr. Heidenreich), Hannover Medical School, Germany; Biogen, Inc. (Drs. Kooijmans, Sandrock, Simonian, and Tsao), Cambridge, MA; Department of Radiology (Dr. Simon), University of Colorado, Denver; and Department of Neurology (Dr. Whitaker), University of Alabama at Birmingham.
Address correspondence and reprint requests to Dr. Jeffrey A. Cohen, Mellen Center–U10; Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195; e-mail: cohenj{at}ccf.org
Background: Interferon ß-1a (IFNß-1a, Avonex) is efficacious in relapsing forms of MS. Studies of other IFNß preparations in secondary progressive MS (SPMS) yielded conflicting results. This study was undertaken to determine whether IFNß-1a slowed disease progression in SP-MS.
Methods: A total of 436 subjects with SPMS and Expanded Disability Status Scale (EDSS) score 3.5 to 6.5 were randomized to receive IFNß-1a (60 µg) or placebo by weekly intramuscular injection for 2 years. The primary outcome measure, used for the first time in a large-scale MS trial, was baseline to month 24 change in the MS Functional Composite (MSFC), comprising quantitative tests of ambulation (Timed 25-Foot Walk), arm function (Nine-Hole Peg Test [9HPT]), and cognition (Paced Auditory Serial Addition Test [PASAT]).
Results: Median MSFC Z-score change was reduced 40.4% in IFNß-1a subjects (-0.096 vs -0.161 in placebo subjects, p = 0.033), an effect driven mainly by the 9HPT and PASAT. There was no discernible benefit on the EDSS, which in this range principally reflects walking ability. IFNß-1a subjects had 33% fewer relapses (p = 0.008). There was significant benefit on eight of 11 MS Quality of Life Inventory subscales. New or enlarging T2-hyperintense brain MRI lesions and gadolinium-enhancing lesions were reduced at months 12 and 24 (both p < 0.001). IFNß-1a was well tolerated by the majority of subjects. Neutralizing antibodies developed in 3.3% of IFNß-1a–treated subjects.
Conclusions: IFNß-1a demonstrated benefit on MSFC progression, relapses, quality of life, and MRI activity in SPMS.
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